FDA Radiology AI Devices

The VX1+ by Volta Medical is an advanced cardiac mapping system that uses machine learning to assist clinicians by automatically or manually annotating 3D anatomical and electrical maps of the heart's atria. It helps identify areas exhibiting complex electrical activity during arrhythmias such as atrial fibrillation, potentially aiding catheter ablation procedures.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

The STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.

Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.

HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.

QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.

Viz RV/LV is a software tool that uses artificial intelligence to automatically measure the size of the right and left ventricles of the heart from CT pulmonary angiogram scans. It provides annotated images and a summary report to assist clinicians in evaluating right ventricular enlargement, potentially aiding diagnosis and treatment decisions.

cvi42 Auto Imaging Software Application is an AI-powered medical imaging software designed to assist clinicians in evaluating cardiovascular MR and CT images. It uses machine learning to semi-automatically contour cardiac structures, perform calcium scoring, and analyze coronary arteries, aiding in diagnosis and quantitative assessment of heart and vessel conditions.

DeepRhythmAI is a cloud-based AI software that automatically analyzes two-lead ECG data to detect cardiac arrhythmias. It supports healthcare professionals by providing analysis results that need to be reviewed and confirmed. It is designed for integration into other medical devices or software platforms and assists clinicians in identifying rhythm issues in adult patients.

AI4CMR v1.0 is a software tool that uses artificial intelligence to automatically analyze cardiac MRI scans to measure cardiac function parameters like ventricle volumes and ejection fraction. It helps clinicians by providing automated quantification of cardiac metrics from MR images, improving workflow efficiency and supporting clinical decisions when integrated into a DICOM viewer.